Anxiolytic Effect of Virtual Reality Immersion Versus Midazolam Premedication in Patients Undergoing Dacryocystorhinostomy Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-30

Brief Summary

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The aim is to investigate the anxiolytic effect, and hemodynamic stability of using virtual reality immersion in adult patients undergoing Dacryocystorhinostomy (DCR) operation under general anesthesia and to compare its effect to that of using Midazolam as a premedication.

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Detailed Description

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Anxiety is a negative emotion characterized by fear, tension, and nervousness. Preoperative anxiety is anxiety due to disease, hospitalization, or scheduled surgery. The most common causes of preoperative anxiety are waiting for surgery, worrying about the operation outcome, being separated from family, anticipating postoperative pain, losing independence, and being afraid of surgery, pain, and death.

Midazolam reduces anxiety by acting on GABAA receptors, resulting in sedation; however, the benefit of midazolam premedication remains debatable, and the drug's side effects include paradoxical reactions, oversedation, reduced blood pressure, and respiratory depression. Regarding this, some clinicians challenge the clinical benefits of benzodiazepine premedication and contend that non-pharmacological treatments alone are sufficient to minimize preoperative anxiety.

Virtual reality is a computer technology that creates the sensation of being immersed in a simulated three-dimensional environment in which the user can interact with the virtual environment. It has also been suggested as a non-pharmaceutical alternative for lowering surgical pain and anxiety.

Dacryocystorhinostomy (DCR) is a procedure that circumvents the blocked tear duct and offers an alternate path for the drainage of tears from the eye to the nose and is most effectively performed under a general anesthetic.

Conditions

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Anxiolytic Effect Virtual Reality Immersion Midazolam Premedication Dacryocystorhinostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual Reality Group

Patient will undergo virtual reality (VR) immersion using oculus.

Group Type EXPERIMENTAL

Virtual Reality Group

Intervention Type OTHER

Patient will undergo virtual reality (VR) immersion using oculus.

Midazolam Group

Patient will receive midazolam premedication only.

Group Type ACTIVE_COMPARATOR

Midazolam Group

Intervention Type DRUG

Patient will receive midazolam premedication only.

Interventions

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Virtual Reality Group

Patient will undergo virtual reality (VR) immersion using oculus.

Intervention Type OTHER

Midazolam Group

Patient will receive midazolam premedication only.

Intervention Type DRUG

Other Intervention Names

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Guided Meditation VR Midazolam

Eligibility Criteria

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Inclusion Criteria

* Aged 18-65.
* Both sexes.
* American Society of Anesthesiologists (ASA) classification: I - II.
* Patient undergoing Dacryocystorhinostomy Surgery (DCR) operation under general anesthesia.

Exclusion Criteria

* Patient refusal.
* Patients with cardiac diseases.
* Patients with renal diseases.
* Patients with drug sensitivity and seizures.
* Substance abuse and addiction.
* Claustrophobia.
* Patients with cerebrovascular disease.
* Psychiatric and cognitive disorder.
* Patients with severe teary eyes and blurring of vision.
* Patients who express discomfort during the test.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No